Muscle Stretching ExercisesNCT04459195
Acute Effects of Static Stretching Duration on Gastrocnemius Muscle Vascularization
A study testing 2 Minute Static Stretching and 5 Minute Static Stretching in people with Muscle Stretching Exercises, run by Yuksek Ihtisas University at 1 site in Turkey (Türkiye).
Trial summary
Stretching effects skeletal muscle flexibility, vascularity and physical performance. The aim of our study is to examine the acute effects of static stretching duration on gastrocnemius muscle vascularization in healthy participants by superb microvascular imaging (SMI) and to compare the effects of 2 and 5 minutes of… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Stretching Exercises
- What is being tested?
- 2 Minute Static Stretching and 5 Minute Static Stretching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jul 2020to 7 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers between the ages of 18-35,
- Without knee, hip, ankle and waist pathology,
- Has not undergone any surgery on the lower extremity.
Who cannot join
- Rheumatic, musculoskeletal, neurological and vestibular problems,
- Bone pathologies,
- Joint laxity,
- Connective tissue disorders
- Diabetes, metabolic syndrome, arthritic or inflammatory problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Investigation of Acute Effects of Static Stretching Duration on Gastrocnemius Muscle Vascularization by Superb Microvascular Imaging Method
Stretching effects skeletal muscle flexibility, vascularity and physical performance. The aim of our study is to examine the acute effects of static stretching duration on gastrocnemius muscle vascularization in healthy participants by superb microvascular imaging (SMI) and to compare the effects of 2 and 5 minutes of static stretching on blood flow.
Read the detailed description
The study will be included 30 healthy volunteers. The participants will be divided into two groups. Static stretching was administered to the gastrocnemius muscle. Stretching applications will be applied to the first group for 2 minutes and to the second group for 5 minutes. Muscle vascularization will be evaluated by a new method, superb microvascular imaging (SMI). SMI is a recently developed ultrasound imaging technique that aims to visualize low velocity and small diameter blood vessel flow.
- Conditions
- Muscle Stretching Exercises
- Being tested
- 2 Minute Static Stretching, 5 Minute Static Stretching
- Keywords
- Gastrocnemius, Static Stretching, Muscle Vascularization, Superb Microvascular Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 Minute Static StretchingBehavioural
Stretching applications will be applied to the first group for 2 minutes. Static stretching exercise will be performed under the supervision of a physiotherapist as 30 seconds of stretching and 30 seconds of rest and and the individuals will be asked to participate in the exercise actively.
5 Minute Static StretchingBehavioural
Stretching applications will be applied to the first group for 5 minutes. Static stretching exercise will be performed under the supervision of a physiotherapist as 30 seconds of stretching and 30 seconds of rest and and the individuals will be asked to participate in the exercise actively.
| Study group | Role | What they receive |
|---|---|---|
| 2 Minute Static stretching | Experimental | Stretching applications will be applied to the first group for 2 minutes . Receives: Behavioral: 2 Minute Static Stretching |
| 5 Minute Static stretching | Experimental | Stretching applications will be applied to the first group for 5 minutes. Receives: Behavioral: 5 Minute Static Stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle vascularization
The evaluation of muscle vascularization will be made using the Superb microvascular imaging method by a radiologist. Superb microvascular imaging is a recently developed ultrasound imaging technique that aims to visualize low velocity and small diameter blood vessel flow.
Measured: Immediately after the application.
Muscle vascularization
The evaluation of muscle vascularization will be made using the Superb microvascular imaging method by a radiologist. Superb microvascular imaging is a recently developed ultrasound imaging technique that aims to visualize low velocity and small diameter blood vessel flow.
Measured: 10 minutes after the application.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start10 Jul 2020
- Primary completion7 Aug 2020
- Study completion7 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Muscle Stretching ExercisesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuksek Ihtisas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kamile UZUN AKKAYA, Yuksek Ihtisas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04459195
- Sponsor's protocol ID
- Kamile U Akkaya
- Status last verified
- Dec 2020
- First submitted
- 30 Jun 2020
- Last updated
- 23 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Caliskan E, Akkoc O, Bayramoglu Z, Gozubuyuk OB, Kural D, Azamat S, Adaletli I. Effects of static stretching duration on muscle stiffness and blood flow in the rectus femoris in adolescents. Med Ultrason. 2019 May 2;21(2):136-143. doi: 10.11152/mu-1859.
PubMed 31063516Maeda N, Urabe Y, Tsutsumi S, Sakai S, Fujishita H, Kobayashi T, Asaeda M, Hirata K, Mikami Y, Kimura H. The Acute Effects of Static and Cyclic Stretching on Muscle Stiffness and Hardness of Medial Gastrocnemius Muscle. J Sports Sci Med. 2017 Dec 1;16(4):514-520. eCollection 2017 Dec.
PubMed 29238251Nakamura M, Ikezoe T, Nishishita S, Umehara J, Kimura M, Ichihashi N. Acute effects of static stretching on the shear elastic moduli of the medial and lateral gastrocnemius muscles in young and elderly women. Musculoskelet Sci Pract. 2017 Dec;32:98-103. doi: 10.1016/j.msksp.2017.09.006. Epub 2017 Sep 25.
PubMed 28988152Jiang ZZ, Huang YH, Shen HL, Liu XT. Clinical Applications of Superb Microvascular Imaging in the Liver, Breast, Thyroid, Skeletal Muscle, and Carotid Plaques. J Ultrasound Med. 2019 Nov;38(11):2811-2820. doi: 10.1002/jum.15008. Epub 2019 Apr 5.
PubMed 30953387
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of Acute Effects of Static Stretching Duration on Gastrocnemius Muscle Vascularization by Superb Microvascular Imaging Method
- ClinicalTrials.gov ID
- NCT04459195
- Acronym / sponsor ID
- Kamile U Akkaya
- Conditions
- Muscle Stretching Exercises
- Keywords
- Gastrocnemius, Static Stretching, Muscle Vascularization, Superb Microvascular Imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Yuksek Ihtisas UniversityUniversity, hospital or other
- Study start
- 10 Jul 2020 (actual)
- Primary completion
- 7 Aug 2020 (actual)
- Study completion
- 7 Aug 2020 (actual)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Stretching effects skeletal muscle flexibility, vascularity and physical performance. The aim of our study is to examine the acute effects of static stretching duration on gastrocnemius muscle vascularization in healthy participants by superb microvascular imaging (SMI) and to compare the effects of 2 and 5 minutes of static stretching on blood flow.
Detailed description
The study will be included 30 healthy volunteers. The participants will be divided into two groups. Static stretching was administered to the gastrocnemius muscle. Stretching applications will be applied to the first group for 2 minutes and to the second group for 5 minutes. Muscle vascularization will be evaluated by a new method, superb microvascular imaging (SMI). SMI is a recently developed ultrasound imaging technique that aims to visualize low velocity and small diameter blood vessel flow.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 Minute Static stretching | Experimental | Behavioral: 2 Minute Static StretchingStretching applications will be applied to the first group for 2 minutes . |
| 5 Minute Static stretching | Experimental | Behavioral: 5 Minute Static StretchingStretching applications will be applied to the first group for 5 minutes. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy volunteers between the ages of 18-35,
- Without knee, hip, ankle and waist pathology,
- Has not undergone any surgery on the lower extremity.
Key exclusion criteria (5 listed)
- Rheumatic, musculoskeletal, neurological and vestibular problems,
- Bone pathologies,
- Joint laxity,
- Connective tissue disorders
- Diabetes, metabolic syndrome, arthritic or inflammatory problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2 Minute Static StretchingStretching applications will be applied to the first group for 2 minutes. Static stretching exercise will be performed under the supervision of a physiotherapist as 30 seconds of stretching and 30 seconds of rest and and the individuals will be asked to participate in the exercise actively. | Behavioural | 2 Minute Static stretching |
| 5 Minute Static StretchingStretching applications will be applied to the first group for 5 minutes. Static stretching exercise will be performed under the supervision of a physiotherapist as 30 seconds of stretching and 30 seconds of rest and and the individuals will be asked to participate in the exercise actively. | Behavioural | 5 Minute Static stretching |
Primary outcome
Muscle vascularization
Time frame: Immediately after the application.
The evaluation of muscle vascularization will be made using the Superb microvascular imaging method by a radiologist. Superb microvascular imaging is a recently developed ultrasound imaging technique that aims to visualize low velocity and small diameter blood vessel flow.
Muscle vascularization
Time frame: 10 minutes after the application.
The evaluation of muscle vascularization will be made using the Superb microvascular imaging method by a radiologist. Superb microvascular imaging is a recently developed ultrasound imaging technique that aims to visualize low velocity and small diameter blood vessel flow.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2020.
- Background: PubMed 31063516Caliskan E, Akkoc O, Bayramoglu Z, Gozubuyuk OB, Kural D, Azamat S, Adaletli I. Effects of static stretching duration on muscle stiffness and blood flow in the rectus femoris in adolescents. Med Ultrason. 2019 May 2;21(2):136-143. doi: 10.11152/mu-1859.
- Background: PubMed 29238251Maeda N, Urabe Y, Tsutsumi S, Sakai S, Fujishita H, Kobayashi T, Asaeda M, Hirata K, Mikami Y, Kimura H. The Acute Effects of Static and Cyclic Stretching on Muscle Stiffness and Hardness of Medial Gastrocnemius Muscle. J Sports Sci Med. 2017 Dec 1;16(4):514-520. eCollection 2017 Dec.
- Background: PubMed 28988152Nakamura M, Ikezoe T, Nishishita S, Umehara J, Kimura M, Ichihashi N. Acute effects of static stretching on the shear elastic moduli of the medial and lateral gastrocnemius muscles in young and elderly women. Musculoskelet Sci Pract. 2017 Dec;32:98-103. doi: 10.1016/j.msksp.2017.09.006. Epub 2017 Sep 25.
- Background: PubMed 30953387Jiang ZZ, Huang YH, Shen HL, Liu XT. Clinical Applications of Superb Microvascular Imaging in the Liver, Breast, Thyroid, Skeletal Muscle, and Carotid Plaques. J Ultrasound Med. 2019 Nov;38(11):2811-2820. doi: 10.1002/jum.15008. Epub 2019 Apr 5.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2 Minute Static Stretching and 5 Minute Static Stretching in people with Muscle Stretching Exercises, run by Yuksek Ihtisas University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle vascularization (time frame: Immediately after the application.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04459195, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2020.